Generics Bulletin Executive Editor Dave Wallace has more than 10 years' experience of reporting on the global generics, biosimilars and value-added medicines industries. Having begun his career in the European chemicals industry, Dave has now spent over a decade with Generics Bulletin, becoming editor from 2018. Bringing his background and education in law to bear on industry litigation as well as national legislative and regulatory affairs, he also keeps a close eye on corporate strategy, personnel moves, and product pipelines. A regular delegate to industry events and conferences, he has a particular interest in local market developments, maintaining close links with national industry representatives. He also organizes and acts as a judge for the annual Global Generics & Biosimilars Award.
Latest From David Wallace
Celltrion has struck a deal with 180 Life Sciences to supply anti-TNF products to support the company’s work in pursuing new indications for off-patent biologics.
Stada has struck a deal to partner with Italy’s NTC to market a portfolio of ophthalmic brands in the MENA region. At the same time, the German generics giant has agreed a distribution deal for the Czech Republic with Latvia’s Kalceks.
Alvotech has suffered a setback in its attempt to gain the first US FDA approval for a higher-strength biosimilar adalimumab rival to Humira, after obstacles preventing facility inspections led the agency to defer action on the firm’s AVT02 candidate.
The FDA has awarded biosimulation specialist Certara a further grant to verify and expand models for assessing virtual bioequivalence, to help enable safer, faster and more cost-effective generic drug development.
Samsung Bioepis has celebrated the FDA’s first ever approval of an ophthalmic biosimilar with its endorsement of the firm’s Byooviz ranibizumab rival to Lucentis. The firm has also signaled a surprising expected launch date in the US, as well as offering expectations for launch in Europe where the biosimilar was also recently approved.
Alvotech and Stada are on the verge of gaining the world’s second ever approval for a higher-strength Humira biosimilar, after the EMA’s CHMP endorsed the firms’ adalimumab under the names Hukyndra and Libmyris at its September meeting.